Lung Cancer Clinical Trial
Cryospray Ablation of Surgical Resection Specimens To Determine Safety And Histological Effect In The Lung
Summary
The purpose of this study is to evaluate the feasibility and general safety in the human airway as well as assess the safety and depth and area of treatment using liquid nitrogen sprayed through a catheter via flexible fiber optic bronchoscopy (FFB) using surgical resection specimens from patients undergoing lobectomy.
Full Description
The primary endpoints for this study are patient safety and the histological effects of cryospray therapy in lobectomy patients.
The proposed study is a single center study to evaluate the safety and treatment effect of sprayed liquid nitrogen through a catheter via FFB using surgical resection specimens from patients undergoing lobectomy.
Eligibility Criteria
Inclusion Criteria:
Age 18 years of age
Lobectomy planned based on clinical situation not related to this study.
Deemed operable based on institutional criteria.
Exclusion Criteria:
Pregnant or nursing
Planning to sire a child while enrolled in the study
Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines.
Refusal or inability to give consent.
Concurrent chemotherapy.
Prior radiation therapy which involved the lungs
Medical contraindication or potential problem that would preclude study participation
Concurrent participation in other experimental studies
Uncontrolled coagulopathy or bleeding diathesis
Serious medical illness, including:
Uncontrolled congestive heart failure
Uncontrolled angina
Myocardial infarction
Cerebrovascular accident within 6 months prior to study entry
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There is 1 Location for this study
Baltimore Maryland, 21237, United States
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